Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

Labcompliance News, August 2005

August 19, 2005

FDA Recommends Withholding Approval of New Drug Applications with API's From Non-Compliant Manufacturer

After an inspection of an API manufacturer in the Czech Republic the FDA recommends to withhold approval of new drug applications that use APIs from the inspected company. Furthermore, the letter states that "Failure to promptly correct these deficiencies may result in the refusal to permit entry of these APIs or finished products made from these APIs into the United States". Deviations have been: Insufficient testing of individual batches, no recording of raw data, inadequate equipment design, no investigation of deviations, equipment not adequately maintained The warning letters can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.

August 19, 2005

Expert Advice for Risk Management

More than 20 professionals from industry, vendors and academy presented models for risk management at IVT's risk management conference in Dublin (June 28/30, 2005). Suggested models for risk management ranged from qualitative assessment through simple documentation of risk scenarios with factors for severity, probability and detectability to complex and more time consuming models like Failure Mode and Effect Analysis (FMEA) and Fault Tree Analysis (FTA). The presenters also introduced most recent guidelines from agency and industry task forces such as ICH, ISPE/GAMP and the Global Harmonization Task Force. To download and learn more about the guidance documents, click here. Compliance with FDA regulations and guidelines, more smooth and trouble free operation and cost savings through optimizing resources for validation and compliance have been mentioned as the main drivers for risk management. Ludwig Huber gave a presentation on "Reducing Compliance Costs by Effectively Using Risk Analysis". He will share his experience with Labcompliance visitors in an audio seminar on July 27.

August 19, 2005

FDA Finds Deviations in Laboratory, Materials and Labeling/Packaging Systems

The FDA conducts risk based system inspections also for API manufacturers. A warning letter from 2004 cited deviations in laboratory, material labeling/packaging systems. The laboratory was cited for not having an adequate impurity profile that identifies organic, inorganic and solvent impurities to monitor unidentified and apparent impurities in the API and the microbiological laboratory failed to document the lot number and expiry date of a compound. The material system did fail not to establish the reliability of the supplier's certificate of analysis (COA), e.g., a complete analysis was not performed with the COA at the appropriate intervals. In addition the company was cited for not proofing incoming labels received from the vendor against the master label. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.